Medical infusion device and methods of use

ABSTRACT

A medical infusion device including a chamber characterized by an upper body joined to a lower body via a reversibly collapsible sidewall. The upper body has a first channel fluidly coupled to a needle and a second channel fluidly coupled to an interior of the chamber. The chamber transitions from a collapsed state to the expanded state to retract the needle by introducing fluid into the interior of the chamber through the second channel.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/283,968,now U.S. Pat. No. 10,549,028, filed Oct. 3, 2016, which is acontinuation in part of U.S. patent application Ser. No. 14/704,221,filed May 5, 2015, now U.S. Pat. No. 9,457,144, which is itself acontinuation of U.S. patent application Ser. No. 14/541,796, filed Nov.14, 2014, now U.S. Pat. No. 9,050,130, which is itself a continuation ofU.S. patent application Ser. No. 14/488,982, filed Sep. 17, 2014, nowabandoned, which itself claims benefit of priority to U.S. provisionalpatent application No. 61/879,550 filed Sep. 18, 2013, now expired. Thedisclosure of medical infusion devices and methods of use from each isherein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention relates generally to medical devices that infuse medicalsamples into implanted ports connected to the cardiovascular system ofpatients and more specifically to a medical infusion device having achamber that volumetrically expands to withdraw and secure a needleafter infusion.

BACKGROUND

Infusion devices that incorporate non-coring needles, such as Huberneedles, are commonly used in hospitals and medical care facilities toadminister chemotherapy, provide intravenous fluids and transfuse blood.Typically these devices are used to administer treatments through amedical port implanted under the skin and connected to a catheter.Accessing the medical port involves inserting the non-coring needle intoa septum at the top of the port. The septum is capable of resealingafter removal of the non-coring needle, thereby allowing multiple usesof a same port.

While these devices provide a reliable approach to administeringtreatment to the patient, their use is also associated with considerablerisk to the patient and medical professional, most notably the risk ofneedle stick injuries and the risk of contamination by bloodbornepathogens and exposure to hazardous drugs. Needle stick injuries mostcommonly occur during the manual removal of the needle from the port.Typically two hands are required to remove the needle, in particular onehand to steady the port in the patient while the other hand forciblypulls the needle from the port. As the removal of the needle requiressome force, at the point the needle becomes free from the skin thesudden release of pressure can cause the needle to rebound—a phenomenonknown as ‘bounce-back’. During this process the hand the health careprofessional uses to steady the port is at risk of a needle-stickinjury. Needle stick injuries carry with them the risk of contaminationby bloodborne pathogens transferred from the patient to the health careprofessional.

Additionally, such infusion devices are often used to administer toxicsubstances such as those used for chemotherapy and the like. Thesesubstances are designed to kill the cancer cells in the patient howeveras their effects are not specific to cancerous cells, accidentalexposure can put the health care professional at risk. Accidentalexposure can occur either as a result of a needle stick injury with adevice used to infuse the chemotherapy and/or by leaks or spillage fromthe needle that can occur after its removal.

Further, such infusion devices often lack pressure bearing structuresabove their pierceable barriers so as to prevent pressure from theirchambers from opening the pierced barrier and leading to an ingress offluid into a patient's implanted medical port. Such devices also lack astructure that prevents the needle from prying open the pierceablebarrier after administration of a drug and causing an ingress of fluidinto a patient's implanted medical port.

Therefore there remains a need for a medical infusion device thatprevents or reduces needle stick injuries and that prevents or reducesexposure to infusion media by leaks or spillage once the needle iswithdrawn from the patient. There also remains a need for a medicalinfusion device with a pressure bearing structure above its pierceablebarrier that also prevents a needle from prying open the pierceablebarrier.

SUMMARY

In light of the risks to both health care professionals and the patientsassociated with the use of medical infusion devices, the presentinvention provides a medical infusion device in a form that prevents orreduces a likelihood of needle stick injuries, exposure to bloodbornepathogens and exposure to infusion samples.

To this end, in a first aspect of the invention a medical infusiondevice is provided including a chamber characterized by an upper bodyjoined to a lower body by a reversibly collapsible sidewall. The upperbody preferably has two channels. The first channel is fluidly coupledto the lumen of a needle, and the second channel is fluidly coupled tothe interior of the chamber at a position distinct and separate from thefirst channel. Each channel is configured for fluid connection to tubingoutside of the chamber. The lower body has a pierceable barrier that canbe pierced by the needle.

The chamber has a collapsed state and an expanded state. The collapsedstate is characterized as the sidewall being collapsed and the needlepiercing entirely through the pierceable barrier. The expanded state ischaracterized as the needle less than entirely piercing through thepierceable barrier. The chamber is configured to transition from thecollapsed state to the expanded state by introducing fluid into theinterior of the chamber through the second channel.

The chamber sidewall can be configured to reversibly collapse and expandusing a variety of approaches, such as by providing the sidewall in abellows-like configuration, characterized as having two or moregenerally linear segments joined by alternating folds at predeterminedfold lines. In a further embodiment, the sidewall is formed as two,three, or more segments that concentrically nest in one another in thecollapsed state. Alternatively, the chamber sidewall can be formed froma foldable, bendable or crumpling polymer without predetermined foldlines.

During infusion of a sample, such as a medication, the chamber isprovided in its collapsed configuration. Volumetric expansion of thechamber retracts the needle at least partially into the chamber.Expansion preferably occurs by introducing a fluid, such as a liquid,into the chamber via the second channel. Volumetric expansion of thechamber lifts the needle through its attachment at the upper body. Insome embodiments, the infusion device includes a visual indicator, suchas a coloring or colored dye powder or concentrate, housed in thechamber, which when suspended in solution visually indicates thepresence of fluid.

In some embodiments, the infusion device includes at least one valve,which may be integrated within the upper body or external and remotefrom the upper body. In some embodiments the valve only regulates flowof fluid into the first channel and thus through the needle for deliveryof an infusion sample into an implanted port of a patient. In otherembodiments the valve only regulates flow of fluid into the secondchannel and thus the chamber interior for volumetric expansion,selectively transitioning the device from the collapsed state to theexpanded state. In still other embodiments, the valve selectivelydirects flow to either the first or second channel and thus between theneedle and chamber interior. In still other embodiments, the valve canprevent fluid access to both the first channel and the second channel.In yet another embodiment flow is directed into the chamber andpermitted to backwash the needle, the first channel, and connectedtubing. In yet another embodiment, the valve is a rotating valve thatrotates parallel to the plane of the needle or rotates transfers to theplane of the needle.

In some embodiments, the upper body and lower body are friction fit orhave complementary locking structures to lock one another in thecollapsed state during infusion and unlock prior to or during volumetricexpansion of the chamber after infusion. The complementary lockingstructures can be twist locks, screw and thread other suitablestructures.

The pierceable barrier permits fluid tight withdrawal of the needle intothe chamber. Preferably, the pierceable barrier is self-sealing. In someembodiments, the piercable barrier is configured as a lower septumpositioned below and preferably adjacent to an upper septum. In furtherembodiments, the lower septum forms a higher pressure seal compared tothe upper septum. In some embodiments the bevel or tip of the needleremains in the upper septum for occlusion and disposal after retraction.In some embodiments, an o-ring encircles the needle for further sealing.In some embodiments the bevel or tip of the needle is fully capturedwithin the chamber such that fluid filling the chamber can backflush theinner lumen of the needle after retraction.

In some embodiments, the chamber deploys a blocking structure to blockthe needle from piercing entirely through the piercable barrier duringor after expansion of the chamber. The blocking structure can be formedas sheet of nonpierceable material, such as metal or metal alloy. Theblocking structure can be in the form of a jam lock that wedges againstthe needle to prevent piercing entirely through the barrier.

In some embodiments, the infusion device includes a mounting base forreversibly mounting the lower body. In such embodiments, the lower bodyis preferably configured such that the base reversibly accepts the lowerbody thereby permitting removal of the chamber from the mounting baseafter expansion of the chamber. That is, the pierceable barrier can formpart of the lower body; and the lower body can be quickly and safelyremoved from the mounting base. The base and lower body can be frictionfit into a throughbore or counterbore in the mounting base or mayreversibly interlock through appropriate interlocking structures. Inother embodiments, the mounting base is integral with the lower body asa single unit that does not release the chamber.

In some embodiments a cap that fits over the upper body. In furtherembodiments the cap and base can have complementary locking structuresfor further securing the chamber in its collapsed state during infusionor for insertion of the needle into a medical port.

In some embodiments, the lower body comprises a rigid sheath extendingupward into the chamber and configured to guide the needle duringexpansion and sheathe the needle in the expanded state. In the collapsedstate, the sheath is preferably nested within a recess in the upper bodyof the chamber and may be friction fit. The sheath may include an accessport to improve access to the lumen of the needle when the chamber isexpanded for backflushing.

In some embodiments an external mechanical guide is positioned outsideof the collapsible sidewall, preferably having an end of travel releasethat upwardly guides the upper body from the base during expansion andreleases the chamber with needle after expansion.

In a related aspect, a medical infusion device is provided, whichincludes a chamber characterized by an upper body fluidly connected to aneedle and joined to a lower body by a reversibly collapsible sidewall.The lower body includes a pierceable barrier that can be pierced by theneedle and includes a lower septum positioned vertically beneath anupper septum. The lower septum forms a higher pressure seal compared tothe upper septum. The chamber has a collapsed state and an expandedstate. The collapsed state is characterized as the sidewall beingcollapsed and the needle piercing entirely through the lower septum todeliver a fluid outside of the device, and the expanded state ischaracterized as the needle terminating within or vertically above theupper septum.

In another related aspect, a method of delivering medication into animplanted medical port is provided, which includes: providing theinfusion device in the collapsed state; piercing the implanted medicalport with the needle; infusing medication into the medical port throughthe needle via the first channel; and introducing fluid into the chambervia the second channel thereby volumetrically expanding the chamber towithdraw the needle from the medical port.

In embodiments where the piercable barrier is configured as a lowerseptum positioned below an upper septum, the method can also includeretracting the needle completely from the lower septum during expansion.In some embodiments, the bevel or tip of the needle is retracted intothe upper septum for occlusion. In further embodiments the bevel or tipof the needle is retracted entirely through the upper septum. In furtherembodiments the method includes continuing to introduce fluid into thechamber to wash the needle. In still further embodiments, the methodincludes continuing to introduce fluid into the chamber to backflush thefirst channel via the needle.

In another related aspect, a method of delivering medication into animplanted medical port is provided using a dual septum configuration,which includes providing the infusion device in the collapsed state;piercing the implanted medical port with the needle; infusing medicationinto the medical port through the needle via the first channel; andretracting the needle to terminate into or above the upper septum.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention can be better understood with reference tothe following drawings, which are part of the specification andrepresent preferred embodiments. The components in the drawings are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention. And, in the drawings, like referencenumerals designate corresponding parts throughout the several views.

FIGS. 1A-D depict an overview of an exemplary technical approach tomedical infusion using a device according to the invention.

FIGS. 2A-F depict an infusion device showing an exemplary mechanism fora twist lock for use in a collapsed configuration and protectivelycapturing the tip of the needle within the pierceable barrier when in anexpanded state.

FIGS. 3A-D depict an infusion device showing an exemplary valvemechanism to selectively deliver fluid into different channels of thedevice from a same exterior tubing.

FIGS. 4A-D depict an infusion device showing an exemplary valvemechanism to selectively deliver fluid into different channels of thedevice from different tubing.

FIGS. 5A-F depict an infusion device showing an exemplary volumetricexpansion of a chamber having a sidewall in a bellows configuration anduse of a friction fit locking mechanism.

FIGS. 6A-J depict an infusion device showing exemplary volumetricexpansion of a chamber having a bellows configuration that overcomesfriction fit attachment of the upper body, lower body and base togetherwith needle sheathing and needle capture approaches.

FIGS. 7A-B depict an infusion device with an exemplary blockingstructure preventing the needle from piercing entirely through thepierceable barrier.

FIGS. 8A-B depict an infusion device with an exemplary externalmechanical guide that upwardly guides the upper body from the baseduring expansion of the chamber and preferably releases the chamberafter the end of travel.

FIGS. 9A-B depict an infusion device showing an exemplary valvepositioned remote from the upper body of the device.

FIGS. 10A-D depict an infusion device showing an exemplary dual septumconfiguration.

FIGS. 11A-C depict an infusion device configured with an additionalo-ring seal.

FIGS. 12A-B depict an alternative bellows configuration with concentricnesting of the sidewall.

DETAILED DESCRIPTION

The object of the invention is to provide medical infusion devices andrelated methods that eliminate or reduce the risk of needle stickinjuries, contamination by bloodborne pathogens, exposure to hazardousfluids and other risks associated with the use of needles inconventional infusion-based methods. The above is achieved at least inpart by providing a medical infusion device that removes an infusionneedle from an implanted medical port using a steady or controlledfluidic force, preferably a hydraulic force, thereby reducingbounce-back injury. In addition, the medical infusion deviceprotectively secures a withdrawn needle to avoid further risks of needlestick injury, exposure to contents of the infused sample, and exposureto patient's biological tissue or fluid. Still further, the inventionprovides a mechanism for backflushing the device to remove residualinfusion medication or sample thereby permitting disposal of the deviceaccording to non-hazardous standards. Still further, the medicalinfusion device provides closed systems consistent with medicallyaccepted safety standards. To this end, use of the invention will reducemultiple hazards associated with infusion-based medical treatments andreduce the cost of disposal.

The skilled artisan will appreciate that the infusion devices andaccompanying methods can be used in a variety of medical treatmentswhere infusion of a fluid is needed. Among these include medicaltreatment where the infusion sample is a hazardous fluid or biohazardousfluid, such as a toxin, suspected toxin, whole blood or components ofwhole blood. Hematology and oncology patients frequently require regularinfusions and therefore are nonlimiting intended patients for the deviceand methods. The skilled artisan will also appreciate that the medicalinfusion devices and methods may be connected to a variety of pumps,gravity-based drip systems, syringes and other devices that can apply acompressed or hydraulic force to administer fluids to the infusiondevice.

For clarity of disclosure, and not by way of limitation, the inventionis discussed according to different detailed embodiments; however, theskilled artisan would recognize that features of one embodiment can becombined with other embodiments and is therefore within the intendedscope of the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this invention belongs. If a definition set forth inthis document is contrary to or otherwise inconsistent with awell-accepted definition set forth in the art, the definition set forthin this document prevails over a contradictory definition.

The term “medical port” or “implanted port” as used herein refers tomedical device that is installed beneath the skin of a patient andconnected to a catheter, which fluidly connects the port to thecirculatory system of the patient, typically a vein. A medical port isconventionally accessed by piercing a septum with a non-coring needle,typically referred to as a Huber needle, to access the port's interiorchamber, which is coupled to a catheter for delivery into the patient'scirculatory system.

The term “infusion” as used herein refers to the transfer of a fluid,such as medication or nutrients, into a patient's circulatory system.The term “infusion” is also intended to include “transfusions”, such astransfusion of whole blood or components of whole blood, including butnot limited to red blood cells, while blood cells, plasma, clottingfactors, and platelets.

The term “fluid” as used herein refers to a substance that continuallydeforms under an applied shear stress. A “fluid” can be liquid or gasbut is preferably liquid. Medications are typically in liquid form wheninfused into the patient's circulatory system through the device.Volumetric expansion of the chamber can use gas as the fluid butpreferably uses liquid.

The term “fluidly coupled” or “fluidly connected” as used herein refersto the joining of two structures, each having a lumen through which afluid may pass. A variety of complementary structures are known in theart for fluid coupling. Among these include luer locks, syringeadapters, and complementary mating structures having a central lumen.

The term “two channels that do not intersect in the upper body” as usedherein refers to two channels that are spatially separated from oneanother such that a fluid cannot pass continuously from one channel tothe other without passing through the chamber.

The term “position distinct and separate” as used herein refers to twoindependent positions that are not shared. The first and second channelsexit the upper body at distinct and separate positions and thus do notshare an exit aperture.

The term “pierceable barrier” as used herein refers to a surface thatmay be pierced by a needle and is preferably a self-sealing septum.

The term “self-sealing” as used herein refers to the ability of thebarrier to form a fluid or liquid tight seal upon withdrawal of aneedle. Self-sealing materials are commonly used in the construction ofseptums for repeated piercing by needles and are incorporated herein byreference.

The term “blocking structure” as used herein refers to a structure thatprevents a needle from entirely traversing the pierceable barrier. The“blocking structure” can be a “nonpierceable blocking structure”, whichas used herein refers to a structure positioned between the tip of theneedle and the pierceable barrier, the structure formed from a material,such as metal or metal alloy, which cannot be pierced by a needle havinga gauge consistent with infusion of medication into a human. Othersuitable blocking structures include a jam lock that wedges against theneedle when the chamber is in an expanded state to prevent passage ofthe needle entirely through the barrier.

The term “closed system” as used herein refers to a medical device thatmechanically prohibits the transfer of environmental contaminants intothe system and escape of hazardous drug or vapor concentrations outsidethe system. A “closed system” is leakproof and airtight.

The term “collapse in a concentrically nested manner” as used hereinrefers to two or more segments able to fit within one another in thecollapsed state such that they are in substantial vertical alignmentwith one another.

Reference will now be made in detail to non-limiting embodiments of thepresent invention by way of reference to the accompanying drawings,wherein like reference numerals refer to like parts, components, andstructures.

Turning to the drawings, FIGS. 1A-D provide an overview of a preferredtechnical approach used by the invention to infuse medication into apatient and to reduce risk of injury and adverse exposure by bothpatient and medical professional while conducting the medical procedure.Collectively, FIGS. 1A-D depict a medical infusion device 100, whichincludes a chamber 120 having an upper end 122, a lower end 124 and asidewall 126, characterized in that the chamber 120 has a collapsedstate (FIG. 1A) and an expanded state (FIG. 1C). As shown in FIG. 1A,the collapsed state is further characterized as having a needle 128,preferably a non-coring or Huber needle, passing through a mounting base130 and capable of accessing a patient's implanted medical port 132.When in the collapsed state, fluid connection between a remote pumpingsource, such as a syringe or infusion pump, and the needle 128 isaccomplished in part through a first channel 134 within an upper body136, which itself is positioned at the upper end 122 of the chamber 120.In particular, the first channel 134 of the upper body 136 acts as aconduit to fluidly connect the needle 128 to tubing 138, which itselfconnects to the remote pumping source, such as the syringe or infusionpump for supplying the infusion medication or infusion sample. Theneedle 128 is affixed to an upper body 136 at the upper end 122, suchthat upward movement of the upper body 136 upwardly moves the needle128. A fluid, such as a liquid medication, can pass through the firstchannel 134, through the needle 128 and into the patient's implantedmedical port, and thus circulatory system. In contrast, FIG. 1C depictsa volumetrically expanded state, characterized as having the chamber 120fluidly coupled to the needle 128. That is, fluid (liquid or gas)retained within the chamber 120 during expansion can access the lumen ofthe needle 128 through the bevel/aperture 128 a. In this state, thebevel 128 a of the needle 128 can be housed within the chamber 120thereby preventing or reducing exposure between the needle 128 and thepatient or medical professional after the infusion procedure. Also inthis state, the needle 128, first channel 134, and tubing 138 are readyfor washing. Washing is accomplished by backflushing the needle 128,first channel 134 and connected tubing 138 by continuing to add fluid tothe expanded chamber, thereby removing residual infusion medication orsample from the device 100, which decreases the cost of disposal sincethe contents are no longer hazardous. For completeness, FIG. 1B depictsthe device 100 transitioning from the collapsed state of FIG. 1A to thevolumetrically expanded state of FIG. 1C by filling the chamber 120 witha fluid through a second channel 140 within the upper body 136.

Turning back to FIG. 1A, the infusion device 100, like the otherembodiments herein, can be initially provided in the expanded state, butit is preferably initially provided in the collapsed state. If providedin the expanded state a through passage having a hydrophobic filter,preferably at the upper body 136, can be provided to permit outgassingof the chamber 120 while collapsing the chamber 120. The devices 100 canbe supplied using sterile packaging methods known in the infusion arts,such as providing a plurality of sterile, individual devices 100 withthe needles 128 covered by protective covers and sealed in tear-away orpeel-away packaging to ensure sterility and safety. Tubing 38, such aspolymer medical tubing connected at its proximal end to an infusion pumpor syringe, can be fluidly coupled at its distal end to the firstchannel 134 or second channel 140 through any suitable connectingstructure that permits passage of a fluid, such as couplings, conduits,adapters, connectors, barbed connectors, luer locks or other suitableconnecting structures. Connection can be accomplished using snap fitconnection, friction fit connection, male to female connection, tongueand groove connection or other approaches known in the medical devicearts for fluidly connecting structures for the passage of fluid, and inparticular liquid medication.

Also shown in FIG. 1A, the collapsed state is further characterized ashaving the upper body 136 in close proximity to a base 130 due to theminimal volume within the chamber 120, which can be accomplished byproviding a chamber sidewall 126 that is folded, bent, crumpled orcollapsed. In some embodiments, the chamber 120 can include a sidewall126 that is formed from a bendable material that permits the bending orfolding of the sidewall 126 at varying regions along its height withoutfollowing a predetermined path or fold line thereby permitting thevolume within the chamber 120 to be reduced by bending, folding orcrumpling the sidewall 126. In other embodiments, the chamber 120includes a bellows configuration or a more ordered folding by followingpredetermined fold lines. In related embodiments the chamber 120 isformed in part from segments that concentrically nest in the collapsedstate.

Turning to FIG. 1B, expanding the chamber 120 involves introducing fluidinto the chamber 120 thereby upwardly extending the sidewall 126 andpulling the needle 128 from the medical port 132 and into the chamber120 for protection against needle stick injury, exposure to bloodbornepathogens, an infusion sample, or other hazardous fluids. The chamber120 can be further guided upward through the addition of an externalmechanical guide positioned outside of the collapsible sidewall 126,preferably having an end of travel release, that upwardly guides theupper body 136 from the base 130 during expansion thereby furtherreducing wobble of the upper body 136 and thus needle 128 duringexpansion of the chamber 120. The external mechanical guide can bejoined at the lower end to the base 130 and at the upper end to theupper body 136 or the cap 142. Upon expansion of the chamber 120 themechanical guide preferably releases the upper body 136 from the base130 permitting removal of the chamber 120. Introduction can be by anysuitable liquid pump or can be by pressurizing or releasing compressedgas, such compressed air. Preferably, while the sidewall 126 is capableof upward extension it is preferably inelastic and preferably does notstretch. This more effectively applies hydraulic force to remove theneedle 128 from the medical port 132 during volumetric expansion of thechamber 120. As such, when configured as a cylinder preferably thesidewall 126 does not significantly bulge radially outward when fullyextended. Examples of such materials are well known in the polymer artssuch as various polypropylenes, polyethylenes or other flexiblepolymers. While the sidewall 126 is preferably inelastic, it could beelastic as long as the modulus of elasticity results in upward extensionof the upper body 134 in the expanded or deployed state.

Returning to FIG. 1A, preferably the chamber 120 remains in itscollapsed state before and during infusion of medication, such asinfusion of a pharmaceutical. To this end, a variety of structures havebeen developed to ensure the chamber 120 remains in its collapsed stateas added assurance. In some configurations the sidewall 126 is coveredfor further protection. In one approach, a removable cap 142 is mountedover the upper body 136 and attached to an outer surface of the base130, such as by complementary threads in a screw cap, tongue and groove,twist lock configuration, or friction fit. Naturally, the cap 142 can beknurled or textured to facilitate its release or removal from the base130, such as after infusing medication but before introducing fluid intothe chamber 120 for expansion. In other embodiments, the cap 142 canunlock from the base 130 by remain locked to the upper body 136 forpulling the upper body 136.

In another embodiment, the chamber 120 is encouraged to remain in itscollapsed state by adding a memory metal or a spiral-like wire structureto the chamber sidewall 126, such as outside of or embedded within thesidewall 126, which requires additional force to upwardly expand thechamber 120. In still other embodiments, magnetic attraction betweenmagnets of opposing poles can ensure the chamber 120 maintains itscollapsed state and depolarization of one or more magnets, such asthrough modulation of an electric current, facilitates its magneticrelease.

In embodiments that include a mounting base 130, such as the embodimentdepicted in FIGS. 1A-D, the infusion device 100 includes a lower body144 at the lower end 124 of the sidewall 126 of the chamber 120. In suchconfigurations, the lower body 144 includes a pierceable barrier 146that retains a fluid tight seal whether or not the barrier 146 ispierced by the needle 128. Preferably the needle is a non-coring needle128. Such materials are well known in the art including various rubbers,polymers or silicone used as self-sealing septums in the manufacturingof vascular access medical ports 132. In addition, the lower body 144can be configured to reversibly engage the base 130, such as by twistlock, tongue and groove, snap lock or the other suitable engagementapproaches; however, friction fit is most preferred. For instance, thelower body 144 can be friction fit along a circumference or perimeter ofa throughbore 148 or a counterbore in the base 130. Therefore, thethroughbore 148 or counterbore can permit both snug engagement of thebase 130 with the lower body 144 and provide a passage through which aneedle 128 may traverse the base 130 when the lower body 144 and base130 are engaged and the chamber 120 is in its collapsed state.

The device 100 itself can be formed from materials and manufacturingmethods well known to those in the medical device field. For instance,the upper body 136, lower body 144, and base 130 may be formed usingconventional injection molding techniques with suitable polymers used inthe formation of many medical devices, such as polypropylenes.Similarly, the sidewall 126 of the chamber 120 may be formed from arubber or bendable polymer then melted, adhered or fused to the upper136 and lower 144 bodies. The pierceable barrier 146 may be formed fromresealable silicone rubber, optionally two silicon units of differentpressure joined to one another. The lower body 144 may be provided withan aperture that is covered or filled with polymer or silicone to formthe pierceable barrier 146. Alternatively, the lower body 144 may itselfbe formed, at least in part, from a pierceable material, such as one ormore self-sealing polymers or silicone to form the pierceable barrier146.

In view of the above and referring collectively to FIGS. 1A-D, a methodof delivering medication into or through an implanted medical port 132is also provided, which includes providing the infusion device 100 in acollapsed configuration, aligning the needle 128 with an implantedinfusion port 132, and pressing the infusion device 100 such that needle128 pierces the patient's skin 150 (shown generally in FIG. 1A), theninto the septum of the implanted port 132. To further assist withinsertion or handling, the uppermost portion of the upper body 136, oran uppermost portion of a cap 142, or a portion of the base 130 may beflattened, convex, concave, flanged, or suitably shaped to accept a handor finger to assist in securely gripping or pressing the infusiondevice. Once the needle pierces the skin 150 and is inserted into thepatient's infusion port 132, the base 130 can be adhesively mounted tothe patient through the use of adhesive mounts 152 positioned along theunderside of the base 130 or by applying tape over outward extendingflanges 154 of the base 130. Infusion of a medical sample isaccomplished by delivering the sample into the first channel 134, whichis fluidly coupled to the needle 128, and thus the interior cavity ofimplanted infusion port 132.

After infusion is complete, the device 100 can be prepared fortransitioning from a collapsed state to an expanded state therebyremoving the needle 128 from the medical port 132 and safely securingthe needle 128. The skilled artisan will appreciate that steps inpreparing to remove the needle 128 may be performed consistent with theparticular approach used for further retaining the infusion device 100in its collapsed configuration. For instance, in some embodiments a cap142 is removed to release the upper body 136 from the base 130. However,in some embodiments, such as those where the cap 142 is friction fit,the cap 142 can be removed from the base 130 by delivering sufficientfluid volume into the chamber 120 to overcome the friction fitattachment.

Exemplary removal of the needle 128 from the medical port 132 and/orpatient is demonstrated operationally in FIG. 1B, which involvesintroducing a fluid to volumetrically expand chamber 120 via the secondchannel 140 to initiate chamber 120 filling and thus upward extension ofthe chamber sidewall 126. The skilled artisan will appreciate that thefluid may be any suitable fluid such as water, saline, phosphatebuffered saline, wash solution, bleach solution or other liquids.Alternatively, compressed gas, such as compressed air, can be applied tothe chamber 120. Preferably, fluid is continually introduced at leastuntil the needle 128 is withdrawn from the patient, and preferably untilthe bevel or tip is completely housed within the chamber 120 therebysurrounding and capturing the needle 128 to avoid injury. Although thesidewall 126 is preferably extendable, it is also preferably inelasticor substantially inelastic such that the sidewall 126 or chamber 120does not elastically stretch more than 10 percent under filling pressuresuch that the upper body 134 can pull the needle 128 upwards. Thesidewall 126 when expanded is preferably cylindrical as shown in FIG. 1Cbut could be arc-shaped, partially spherical or any other suitableshape.

In a preferred embodiment, fluid is continually introduced into thechamber 120 after the needle 128 is completely housed within the chamber120 such that the introduced fluid is volumetrically displaced tobackwash the lumen of the 128 a of needle 128. The skilled artisan willappreciate that still further introduction of fluid into the chamber 120via the second channel 140 will continue to push or backwash the lumen128 a of the needle 128, the first channel 134 and any connected tubing138 or connectors unless obstructed. In some embodiments, a visualindicator is stored in the chamber 120, such as a colored dye orvisually detectable compound, which can be provided as a powder orconcentrate and that colors the backflushing solution to visuallymonitor progress of backflushing. In some embodiments a portion of thechamber 120 interior is spray coated with a dye that can be dissolved inthe backflushing solution for coloring. By visually monitoringbackflushing, the user is notified when any potentially hazardousmedication or sample is removed from the device 100 for disposal. Oncebackflushing is complete any tubes connected to the device can beclamped or removed. Thus, continuing to backwash the first channel 134and tubing 138 may provide a further safety feature by preventingexposure during detachment of the device 100 from an infusion pump orsyringe and allows disposal without classification as a chemical orbiohazard.

As show in FIG. 1D, the lower body 144 can be disengaged from the base130 after filling the chamber 120 and capturing the needle 128 withoutrisk of needle stick, exposure to the infused medication or the fluidwithin the chamber as the pierceable barrier 146 of the lower body 144maintains a fluid tight seal. That is, the pierceable barriersufficiently seals the chamber 120 to prevent leaking thereby providinga closed system once the tubes 138 are clamped, a valve integrated intothe upper body 142 is closed, or a remote valve positioned away from theupper body 136 is closed. As further protection the chamber 120 may alsoinclude a blocking structure configured to block access through thepiercable barrier 146 by the needle 128. The base 130 can then beremoved from the patient and the infusion device 100 safely disposed.

In a related embodiment shown in FIGS. 2A-F, a medical infusion device200 is provided, which includes a chamber 220 defined by an upper body236, a sidewall 226, and a lower body 244, characterized in that thechamber 220 has a collapsed state (FIGS. 2C and 2E shown withoutsidewall 226 for simplification) and an expanded state (FIG. 2D). Theskilled artisan would appreciate that the lower body 244 could bedivided into a mounting base with lower body insert more akin to FIG. 1if desired. As shown in FIG. 2C, the collapsed state is furthercharacterized as having a needle 228, preferably a non-coring or Huberneedle affixed to the upper body 236, passing through the pierceablebarrier 246 of the lower body 244 and thus being capable of accessing apatient's implanted medical port. Fluid connection between a remotesource, including but not limited to a syringe, infusion pump, and adrip bag, and the needle 228 is accomplished in part through a firstchannel 234 within an upper body 236, which itself is positioned at theupper end of the chamber 220 (FIG. 2A). In particular, the first channel234 of the upper body 236 is fluidly connected to the needle 228 and canbe fluidly coupled to tubing 238, which itself connects to a remotepumping source such as the syringe or infusion pump. Accordingly, aliquid medication can pass through the first channel 234, through theneedle 228 and into the patient.

In contrast, FIG. 2D depicts a volumetrically expanded state (alsoreferred to as a deployed state), characterized as having the bevel ofthe needle 228 at or above the bottom most plane of the lower body 244and fluid retained in the chamber 220. For completeness, FIG. 2A depictsthe medical device 200 transitioning from the collapsed state of FIG. 2Cto the expanded state of FIG. 2D by filling the chamber 220 with a fluidthrough a second channel 240 within the upper body 236. The chamber 220can be further guided upward through the addition of an externalmechanical guide positioned outside of the collapsible sidewall 226,that upwardly guides the upper body 236 from the lower body 244 duringexpansion thereby further reducing wobble of the upper body 236 and thusneedle 228 during expansion of the chamber 220. The external mechanicalguide can be joined at the lower end to the lower body 244 and at theupper end to the upper body 236.

It is notable that the two channels, 234, 240, do not intersect in theupper body 236. That is, the first channel 234 and the second channel240 do not directly, fluidly communicate with one another within theupper body 236. In the collapsed state (FIG. 2C), the first channel 234is connected to the needle 228 to infuse medication directly into thepatient. In the expanded state (FIG. 2D), preventing the intersectionbetween the first channel 234 and second channel 240 within the upperbody 236 effectively cleans the outside and inside surfaces of theneedle 228 from hazardous blood borne pathogens and toxic medications toprotect the user. In particular, by avoiding intersection between thetwo channels 234, 240 in the upper body 236, wash solution pumped intothe second channel 240 passes around and through the needle 228 beforepassing through the first channel 234 to exit the device 200.

The device 200 can be formed from materials and manufacturing methodsknown to those in the medical device field. For instance, the upper body236 and lower body 244 may be formed using conventional injectionmolding techniques with suitable polymers used in the formation of manymedical devices such as polypropylene and other polymers used in theconstruction of medical devices. Similarly, the sidewall 226 of thechamber 220 may be formed from rubber or foldable polymer then adheredor fused to the upper body 236 and lower body 244. The pierceablebarrier 246 may be formed from self-sealing silicone rubber. The lowerbody 244 may be provided with an aperture that is covered or filled withpolymer or silicone to form the pierceable barrier 246. Alternatively,the lower body 244 may itself be formed, at least in part, from apierceable material, such as a self-sealing polymer to form thepierceable barrier 246.

This embodiment exemplifies features that may be incorporated into otherembodiments, namely, the upper body 236 and lower body 244 havecomplementary interlocking structures 256 a, 256 b, such as a twist-lockor interlocking bayonet and catch, where the upper body 236 and lowerbody 244 interlock to further ensure that the chamber 220 (the sidewall226 removed for simplicity of viewing in FIGS. 2B, C, E, F) remains in acollapsed state during infusion. In addition, as depicted in FIGS. 2B-F,the piercable barrier 246 may be configured to protectively hold theneedle 228 when in the device is in the expanded state.

Accordingly, use of the device shown in FIGS. 2A-F can provide a methodof delivering medication into or through an implanted medical port,which includes providing the infusion device 200 in a collapsedconfiguration, aligning the needle 228 with an implanted infusion port,and pressing the infusion device 200 such that needle 228 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the uppermost portion of the upperbody 236, or a portion of the lower body 244 may be flattened, convex,concave, flanged, curved or suitably shaped to accept a hand or fingerto assist in securely gripping or pressing the infusion device 200. Oncethe needle 228 pierces the skin and is inserted into the patient'sinfusion port, the lower body 244 can be adhesively mounted to thepatient through the use of adhesive mounts positioned along theunderside of the lower body 244 or by applying tape over outwardextending flanges of the lower body 244. Infusion of a medical sample isaccomplished by delivering the sample into the first channel 234, whichis fluidly coupled to the needle 228, and thus implanted infusion port.

After infusion is complete, the upper body 236 is rotated in relation tothe lower body 244 such that the interlocking structures 256 a, 256 bare released. The upper body 236 can then be pulled to retract theneedle 228, or a fluid is introduced into the expandable chamber 220 viathe second channel 240 to initiate volumetric chamber 220 filling andupward extension of the chamber sidewall 226. The skilled artisan willappreciate that the fluid may be any suitable fluid such as water,saline, phosphate buffered saline, wash solution, bleach solution orother liquids. Alternatively, compressed gas, such as compressed air,can be applied to the chamber 220. Preferably, fluid is continuallyintroduced at least until the needle 228 is withdrawn from the port, anduntil the bevel or tip of the needle 228 is at or above the lowermostplane of the lower body 244. In the expanded or deployed state theneedle 228 may remain captured within the piercable barrier 246, whichacts to seal the bottom of the chamber 220 and retain the fluid. Thedevice 200 is then removed from the patient. In other embodiments, theneedle 228 is entirely withdrawn into the chamber 220 to permitbackflushing of the needle 228, channel 234 and optionally connectedtubing 238. As with the embodiment above, a visual indicator may beemployed to monitor backflushing to ensure removal of potentiallyhazardous medication or solution and therefore may notify the user whenthe device 200 may be disposed of without special designation as ahazardous material. Further protection against needle stick can beaccomplished by providing a blocking structure or a nonpierceableblocking structure configured to block access through the pierceablebarrier 246 by the needle 228 upon expansion.

In another related embodiment shown in FIGS. 3A-D, a medical infusiondevice 300, is provided, which includes a chamber 320 having an upperbody 336, a sidewall 326, and a lower body 344, characterized in thatthe chamber 320 has a collapsed state (FIG. 3B with sidewall 326 removedfor simplicity for viewing) and an expanded state (FIGS. 3D). Theskilled artisan would appreciate that the lower body 344 could bedivided into a mounting base with lower body insert more akin to FIG. 1if desired. As shown in FIG. 3B, the collapsed state is furthercharacterized as having a needle 328, preferably a non-coring or Huberneedle affixed to the upper body 336, passing through the lower body 244and thus being capable of accessing a patient's implanted medical port.Fluid connection between a remote source, including but not limited to asyringe or infusion pump, with the needle 328 is accomplished in partthrough a valve 358, which forms part of the upper body 336 andselectively accesses either the needle 328 or a passage 340 to the innerchamber 320. In particular, the valve 358 selectively connects a sametubing 338 to either the needle 328 or the inner chamber 320 at one endand a remote pumping source such as one or more syringes or infusionpumps at the other end through one or more suitable connectors, inparticular one or more y-connectors or remote valves positioned awayfrom the upper body 336. Accordingly, a liquid medication can passthrough the valve 358, through the needle 328 and into the patient.

In contrast, FIG. 3D depicts an expanded or deployed state,characterized as having the tip of the needle 328 at or above the bottommost plane of the lower body 344 such that the medical profession isprotected from needle stick. For completeness, FIG. 3A depicts themedical device 300 transitioning from the collapsed state of FIG. 3B tothe expanded state of FIG. 3D by selecting the valve 358 to access theinner chamber 320 and filling the chamber 320 with a fluid. The chamber320 can be further guided upward through the addition of an externalmechanical guide positioned outside of the collapsible sidewall 326 thatupwardly guides the upper body 336 from lower body 344 during expansionthereby further reducing wobble of the upper body 336 and thus needle328 during expansion of the chamber 320. The external mechanical guidecan be joined at the lower end to the lower body 344 and at the upperend to the upper body 336.

It is notable that the two channels, 334, 340, do not intersect in theupper body 336. That is, the first channel 334 and the second channel340 do not directly, fluidly communicate with one another within theupper body 336 due to the valve 358. In the collapsed state (FIG. 3B),the first channel 334 is connected to the needle 328 to infusemedication directly into the patient.

The device 300 can be formed from materials and manufacturing methodsknown to those in the medical device field. For instance, the upper body336 and lower body 344 may be formed using conventional injectionmolding techniques with suitable polymers used in the formation of manymedical devices such as polypropylenes of other suitable polymers.Similarly, the sidewall 326 of the chamber 320 may be formed from rubberor foldable polymer then adhered or fused to the upper body 336 andlower body 344. The pierceable barrier 346 may be formed fromself-sealing silicone rubber. The lower body 344 may be provided with anaperture that is covered or filled with polymer or silicone to form thepierceable barrier 346. Alternatively, the lower body 344 may itself beformed, at least in part, from a pierceable material, such as aself-sealing polymer or silicone to form the pierceable barrier 346.

This embodiment exemplifies features that may also be incorporated intoother embodiments, namely, a rotating valve 358 that forms part of theupper body 336 and selectively delivers fluid to either the needle 328or the chamber 320 from a same tubing 338 thereby permitting the user toselectively deliver fluid to either the needle 328 or the chamber 320through rotation of a handle 360, which is typically a 180 degreerotation. Thus, operation of the infusion device 300 would typicallyinclude rotating the handle 360. Closing the valve 358 can beaccomplished by about 45 to 135 degree rotation of the handle 360 toprevent access to both channels 334, 340.

Accordingly, use of the device shown in FIGS. 3A-D can provide a methodof delivering medication into or through an implanted medical port,which includes providing the infusion device 300 in a collapsedconfiguration with the valve 358 designating fluid communication withthe needle 328, aligning the needle 328 with an implanted infusion port,and pressing the infusion device 300 such that needle 328 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the uppermost portion of the upperbody 336, or a portion of the lower body 344 may be flattened, convex,concave, flanged, curved or suitably shaped to accept a hand or fingerto assist in securely gripping or pressing the infusion device 300. Oncethe needle 328 pierces the skin and is inserted into the patient'sinfusion port, the lower body 344 can be adhesively mounted to thepatient through the use of adhesive mounts positioned along theunderside of the lower body 344 or by applying tape over outwardextending flanges of the lower body 344. Infusion of a medical sample isaccomplished by delivering the sample into the first channel 334, whichis fluidly coupled to the needle 328, and thus implanted infusion port.

After infusion is complete, the upper body 336 is rotated in relation tothe lower body 344 such that the interlocking structures 356 a, 356 bare released. The handle 360 is rotated to designate fluid connectionwith the inner chamber 320. A fluid is introduced into the expandablechamber 320 via the same tubing 338 to initiate volumetric chamber 320filling and upward extension of the chamber sidewall 326. The skilledartisan will appreciate that the fluid may be any suitable fluid such aswater, saline, phosphate buffered saline, wash solution, bleach solutionor other liquids. Alternatively, compressed gas, such as compressed air,can be applied to the chamber 320. Preferably, fluid is continuallyintroduced at least until the needle 328 is withdrawn from the port, anduntil the bevel or tip of the needle 328 is at or above the lowermostplane of the lower body 344. In the expanded or deployed state theneedle 328 may remain captured within the pierceable barrier 346, whichacts to seal the bottom of the chamber 320. Alternatively, the bevel ortip of the needle 328 may be captured entirely within the chamber 320and away from the piercable barrier 346. The device 300 is then removedfrom the patient. The chamber 320 is therefore a closed system definedby the piercable barrier 346 and selection of the valve 358 in a closedstate. Further protection against needle stick can be accomplished byproviding a blocking structure configured to block access entirelythrough the piercable barrier 346 by the needle 328 upon expansion.

In another related embodiment shown in FIGS. 4A-D, a medical infusiondevice 400, is provided, which includes a chamber 420 having an upperbody 436, a sidewall 426, and a lower body 444, characterized in thatthe chamber 420 has a collapsed state (FIG. 4B with sidewall 426 removedfor viewing simplicity) and an expanded state (FIGS. 4C, 4D). Theskilled artisan would appreciate that the lower body 444 could bedivided into a mounting base with lower body insert more akin to FIG. 1if desired. As shown in FIG. 4B, the collapsed state is furthercharacterized as having a needle 428, preferably a non-coring or Huberneedle affixed to the upper body 436, passing through the lower body 444and thus being capable of accessing a patient's implanted medical port.Fluid connection between a remote source, including but not limited to asyringe or infusion pump, and the needle 428 is accomplished in partthrough an integrated valve 458 that selectively prevents or permitsaccess to a first channel 434 within an upper body 436, which itself ispositioned at the upper end of the chamber 420. In particular, the firstchannel 434 of the upper body 436 is fluidly connected to the needle 428and can be fluidly coupled to tubing 428 by the appropriate valve 458position, thereby permitting infusion from a remote pumping source suchas the syringe or infusion pump. Accordingly, a liquid medication canpass across the valve 458, through the first channel 434, through theneedle 428 and into the patient.

In contrast, FIGS. 4C, 4D depict a volumetrically expanded state (alsoreferred to as a deployed state), characterized as having the bevel ortip of the needle 428 at or above the bottom most plane of the lowerbody 444. For completeness, FIG. 4A depicts the medical device 400transitioning from the collapsed state of FIG. 4B to the expanded stateof FIGS. 4C, 4D by filling the chamber 420 with a fluid through a secondchannel 440 within the upper body 436. The chamber 420 can be furtherguided upward through the addition of an external mechanical guidepositioned outside of the collapsible sidewall 426 that upwardly guidesthe upper body 436 from the lower body 444 during expansion therebyfurther reducing wobble of the upper body 436 and thus needle 428 duringexpansion of the chamber 420. The external mechanical guide can bejoined at the lower end to the lower body 444 and at the upper end tothe upper body 436.

It is notable that the two channels, 434, 440, do not intersect in theupper body 436. That is, the first channel 434 and the second channel440 do not directly, fluidly communicate with one another within theupper body 436. In the collapsed state (FIG. 4B), the first channel 434is connected to the needle 428 to infuse medication directly into thepatient. In the expanded state (FIGS. 4C, 4D), preventing theintersection between the first channel 434 and second channel 440 withinthe upper body 436 provides a mechanism to retract the needle usinghydraulic pressure.

The device 400 can be formed from materials and manufacturing methodsknown to those in the medical device field. For instance, the upper body436 and lower body 444 may be formed using conventional injectionmolding techniques with suitable polymers used in the formation of manymedical devices such as polypropylenes or other polymers. Similarly, thesidewall 426 of the chamber 420 may be formed from rubber or foldablepolymer then adhered or fused to the upper body 436 and lower body 444.The pierceable barrier 446 may be formed from resealable siliconerubber. The lower body 444 may be provided with an aperture that iscovered or filled with polymer or silicone to form the pierceablebarrier 446. Alternatively, the lower body 444 may itself be formed, atleast in part, from a pierceable material, such as a self-sealingpolymer or silicone to form the pierceable barrier 446.

This embodiment exemplifies features that may also be incorporated intoother embodiments, namely, a rotating valve 458 that forms part of theupper body 436 that selectively prevents or permits fluid deliverythrough the needle 428, and interlocking structures 456 a, 456 b thatare rubber protrusions and corresponding recesses for detachment orrelease by chamber 420 filling. Thus, operation of the infusion device400 would typically include rotating the handle 460 to open or close thevalve 458 and releasing the interlocking structures 456 a, 456 b inresponse to increasing fluid pressure during chamber 420 filling.

Accordingly, use of the device as shown in FIGS. 4A-D can provide amethod of delivering medication into or through an implanted medicalport, which includes providing the infusion device 400 in a collapsedconfiguration, selecting the valve 458 to fluidly connect with theneedle 428, aligning the needle 428 with an implanted infusion port, andpressing the infusion device 400 such that the needle 428 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the uppermost portion of the upperbody 436, or a portion of the lower body 444 may be flattened, convex,concave, flanged, curved or suitably shaped to accept a hand or fingerto assist in securely gripping or pressing the infusion device 400. Oncethe needle 428 pierces the skin and is inserted into the patient'sinfusion port, the lower body 444 can be adhesively mounted to thepatient through the use of adhesive mounts positioned along theunderside of the lower body 444 or by applying tape over outwardextending flanges of the lower body 444. Infusion of a medical sample isaccomplished by delivering the sample through the valve 458, throughfirst channel 434, which is fluidly coupled to the needle 428, and intothe implanted infusion port.

After infusion is complete, the handle 464 is rotated so that the valve458 designates fluid connection with the inner chamber 420. A fluid isintroduced into the expandable chamber 420 to initiate volumetricchamber 420 filling and upward extension of the chamber sidewall 426,which overcomes the holding force of the rubber protrusions. The skilledartisan will appreciate that the fluid may be any suitable fluid such aswater, saline, phosphate buffered saline, wash solution, bleach solutionor other liquids. Alternatively, compressed gas, such as compressed air,can be applied to the chamber 420. Preferably, fluid is continuallyintroduced at least until the needle 428 is withdrawn from the port, anduntil the bevel or tip of the needle 428 is at or above the lowermostplane of the lower body 444. In the expanded or deployed state theneedle 428 may remain captured within the piercable barrier 446, whichacts to seal the bottom of the chamber 420 and retain the fluid.

Alternatively, the needle can be raised such that the bevel or tip ishoused within the chamber 420. The device 400 is then removed from thepatient. Continued flow of solution into the chamber would thenbackflush the needle 428, the first channel 434 and the tubing 438. Aswith the embodiments above, a visual indicator may be employed tomonitor backflushing to ensure removal of potentially hazardousmedication or solution and therefore may notify the user when the device400 may be disposed of without special designation as a hazardousmaterial. Further protection against needle stick can be accomplished byproviding a blocking structure configured to block access entirelythrough the pierceable barrier 426 by the needle 428 upon expansion.

In another related embodiment shown in FIGS. 5A-E, a medical infusiondevice 500, is provided, which includes a chamber 520 defined by anupper body 536 a sidewall 526, and a lower body 544, characterized inthat the chamber 520 has a collapsed state (FIG. 5B) and an expandedstate (FIGS. 5C, 5D). The skilled artisan would appreciate that thelower body 544 could be divided into a mounting base with lower bodyinsert more akin to FIG. 1 if desired. As shown in FIG. 5B, thecollapsed state is further characterized as having a needle 528,preferably a non-coring or Huber needle affixed to the upper body 536,passing through the lower body 544 and thus being capable of accessing apatient's implanted medical port. Fluid connection between a remotesource, including but not limited to a syringe or infusion pump, and theneedle 528 is accomplished in part through a first channel 534 within anupper body 536, which itself is positioned at the upper end of thechamber 520. In particular, the first channel 534 of the upper body 536is fluidly connected to the needle 528 and can be fluidly coupled totubing 538 thereby permitting infusion from a remote pumping source suchas the syringe or infusion pump. Accordingly, a liquid medication canpass across through the first channel 534, through the needle 528 andinto the patient.

In contrast, FIGS. 5C-5D depict an expanded state (also referred to as adeployed state), characterized as having the bevel or tip of the needle528 at or above the bottom most plane of the lower body 544. Transitionfrom a collapsed state to an expanded or deployed state occurs byfilling the chamber 520 with a fluid through a second channel 540 withinthe upper body 536. The chamber 520 can be further guided upward throughthe addition of an external mechanical guide positioned outside of thecollapsible sidewall 526 that upwardly guides the upper body 536 fromthe lower body 544 during expansion thereby further reducing wobble ofthe upper body 536 and thus needle 528 during expansion of the chamber520. The external mechanical guide can be joined at the lower end to thelower body 544 and at the upper end to the upper body 536.

It is notable that the two channels, 534, 540, do not intersect in theupper body 536. That is, the first channel 534 and the second channel540 do not directly, fluidly communicate with one another within theupper body 536. In the collapsed state (FIG. 5B), the first channel 534is connected to the needle 528 to infuse medication directly into thepatient. In the expanded state (FIG. 5C), preventing the intersectionbetween the first channel 534 and second channel 540 within the upperbody 536 effectively cleans the outside and inside surfaces of theneedle 528 from hazardous bloodborne pathogens and toxic medications toprotect the user. In particular, by avoiding intersection between thetwo channels 534, 540 in the upper body 536, wash solution pumped intothe second channel 540 passes around and through the needle 528 beforepassing through the first channel 534 to exit the device 500.

The device 500 can be formed from materials and manufacturing methodsknown to those in the medical device field. For instance, the upper body536 and lower body 544 may be formed using conventional injectionmolding techniques with suitable polymers used in the formation of manymedical devices such as polypropylenes or other polymers. Similarly, thesidewall 526 of the chamber 520 may be formed from rubber or foldablepolymer then adhered or fused to the upper body 536 and lower body 544.The pierceable barrier 546 may be formed from resealable siliconerubber. The lower body 544 may be provided with an aperture that iscovered or filled with polymer or silicone to form the pierceablebarrier 546. Alternatively, the lower body 544 may itself be formed, atleast in part, from a pierceable material, such as a self-sealingpolymer or silicone to form the pierceable barrier 546.

This embodiment exemplifies features that may also be incorporated intoother embodiments, namely, bendable detent connectors 556 a, 556 b toensure the chamber 520 remains in a collapsed state during infusion of amedical sample. Further, the collapsible sidewall 526 of the chamber 520is provided in a bellows configuration, where a series of segments 566a, 566 b between alternating folds 568 a, 568 b are foldable like anaccordion in a predetermined or bellows-like configuration. In thebellows-like configuration the segments 566 a, 566 b between folds 568a, 568 b can be rigid, flexible or bendable; however, the chambersidewall 526 should fold at the predetermined fold lines 568 a, 568 b.

Accordingly, use of the device as shown in FIGS. 5A-E can provide amethod of delivering medication into or through an implanted medicalport, which includes providing the infusion device 500 in a collapsedconfiguration, aligning the needle 528 with an implanted infusion port,and pressing the infusion device 500 such that needle 528 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the uppermost portion of the upperbody 536, or a portion of the lower body 544 may be flattened, convex,concave, flanged, curved or suitably shaped to accept a hand or fingerto assist in securely gripping or pressing the infusion device 500. Oncethe needle 528 pierces the skin and is inserted into the patient'sinfusion port, the lower body 544 can be adhesively mounted to thepatient through the use of adhesive mounts positioned along theunderside of the lower body 544 or by applying tape over outwardextending flanges of the lower body 544. Infusion of a medical sample isaccomplished by delivering the sample through the first channel 534,which is fluidly coupled to the needle 528, and into the implantedinfusion port.

After infusion is complete, a fluid is introduced into the expandablechamber 520 to initiate chamber 520 filling, release of the bendabledetent connectors 556 a, 556 b, and upward extension of the chambersidewall 526. The skilled artisan will appreciate that the fluid may beany suitable fluid such as water, saline, phosphate buffered saline,wash solution, bleach solution or other liquids. Alternatively,compressed gas, such as compressed air, can be applied to the chamber520. Preferably, fluid is continually introduced at least until theneedle 528 is withdrawn from the port, and until the bevel or tip of theneedle 528 is at or above the lowermost plane of the lower body 544. Inthe expanded or deployed state the needle 528 may remain captured withinthe pierceable barrier 546, which acts to seal the bottom of the chamber520. Alternatively, the needle can be raised such that the bevel or tipis housed within the chamber 520. The device 500 is then removed fromthe patient. Continued flow of solution into the chamber would thenbackflush the needle 528, the first channel 534 and the tubing 538. Aswith the embodiment above, a visual indicator may be employed to monitorbackflushing to ensure removal of potentially hazardous medication orsolution and therefore may notify the user when the device 500 may bedisposed of without special designation as a hazardous material. Furtherprotection against needle stick can be accomplished by providing ablocking structure configured to block access through the pierceablebarrier 546 by the needle 528 upon expansion.

In another related embodiment shown in FIGS. 6A-J, a medical infusiondevice 600, is provided, which includes a chamber 620 having an upperbody 636, a sidewall 626, and a lower body 644, shown releasablyfriction fit to a mounting base 630, characterized in that the chamber620 has a collapsed state (FIGS. 6A-F) and an expanded state (FIGS.6G-J). The lower body 644 could be formed as a single unit with themounting base 630 if selective release of the chamber 620 is from a base630 is not desired. As shown in FIG. 6D, the collapsed state is furthercharacterized as having a needle 628, preferably a non-coring or Huberneedle affixed to the upper body 636, passing through the lower body 644and thus capable of accessing a patient's implanted medical port.Although the device 600 is preferably provided in the collapsed state,collapsing the device 600 can involve downwardly pushing the upper body636 against the lower body 644. A hydrophobic filter 676 in a throughpassage into the chamber 620 may allow air to escape from the chamber620 while collapsing the chamber 620. Fluid connection between a remotesource, including but not limited to a syringe or infusion pump, and theneedle 628 is accomplished in part through a first channel 634 within anupper body 636, which itself is positioned at the upper end of thechamber 620. In particular, the first channel 634 of the upper body 636acts as a conduit to fluidly connect the lumen of the needle 628 totubing 638 thereby permitting infusion from a remote pumping source suchas the syringe or infusion pump through the needle 628. Accordingly, aliquid medication can pass through the first channel 634, through theneedle 628 and into the patient's implanted port.

In contrast, FIG. 6H depicts an expanded or deployed state,characterized as having the bevel or tip of the needle 628 at or abovethe bottom most plane of the lower body 644 and preferably eithersecurely held in the pierceable barrier 646 as shown in FIG. 6J orhoused within the chamber 620 as shown in FIG. 6H. As shown in FIGS. 6D,6F, 6G, a tubular sheath 668 forms part of the lower body 644 of thechamber 620 and extends upward at least partially along the height ofthe chamber 620 acting as a guiding structure to further guide andretain the needle 628 in proper linear alignment during deployment ofthe infusion device 600 and may act to sheathe the bevel or tip of theneedle 628 when entirely captured by the chamber 620 as shown in FIG.6H. The sheath 668 may also be provided with an access port 670 to moreefficiently fluidly access a sheathed needle 628 by fluid contents ofthe chamber 620. Transitioning from a collapsed state to an expanded ordeployed state occurs by filling the chamber 620 with a fluid through asecond channel 640 acting as a conduit through the upper body 636. Thechamber 620 can be further guided upward through the addition of anexternal mechanical guide positioned outside of the collapsible sidewall626, preferably having an end of travel release, that upwardly guidesthe upper body 636 from the base 630 during expansion thereby furtherreducing wobble of the upper body 636 and thus needle 628 duringexpansion of the chamber 620. The external mechanical guide can bejoined at the lower end to the base 630 and at the upper end to theupper body 636. Upon expansion of the chamber 620, preferably themechanical guide releases the upper body 636 from the base 630 therebyreleasing the chamber 620 with needle 628.

It is notable that the two channels, 634, 640, do not intersect in theupper body 636. That is, the first channel 634 and the second channel640 do not directly, fluidly communicate with one another within theupper body 636. In the collapsed state (FIGS. 6A-F), the first channel634 is connected to the needle 628 to infuse medication directly intothe patient. In the expanded state (FIGS. 6G-J), preventing theintersection between the first channel 634 and second channel 640 withinthe upper body 636 effectively cleans the outside and inside surfaces ofthe needle 628 from hazardous bloodborne pathogens and toxic medicationsto protect the user. In particular, by avoiding intersection between thetwo channels 634, 640 in the upper body 636, wash solution pumped intothe second channel 640 passes around and through the needle 628 beforepassing through the first channel 634 to exit the device 600.

The device 600 can be formed from materials and manufacturing methodsknown to those in the medical device arts. For instance, the upper body636, lower body 644, base 630 and sheath 668 may be formed usingconventional injection molding techniques with suitably rigid polymersused in the formation of many medical devices, such as polypropylene orpolymer. Similarly, the sidewall 626 of the chamber 620 may be formedfrom rubber or foldable polymer then adhered or fused to the upper body636 and lower body 644. The pierceable barrier 646 may be formed fromresealable silicone rubber. The lower body 644 may be provided with anaperture that is covered or filled with polymer or silicone to form thepierceable barrier 446, preferably in alignment with the sheath 668.Alternatively, the lower body 644 may itself be formed, in part, from apierceable material, such as a self-sealing polymer or silicone to formthe pierceable barrier 646.This embodiment exemplifies features that mayalso be incorporated into the other embodiments, namely, friction fitconnection about the perimeter of the upper body 636 and the base 630when the infusion device 600 is provided in the collapsed state. Inaddition, by providing a recess 674 in the upper body 636 for nestingthe sheath 668 as shown in FIGS. 6D, 6H, further friction fit connectionbetween the upper body 636 and the lower body 644 can be providedthereby eliminating the desire for additional locking structures tosecurely maintain the infusion device 600 in the collapsed state. Inother embodiments, the recess 674 is spaced apart from the sheath 668 toavoid friction fitting. Still further, by forming a gap 672 between theupper body 636 that is sized to contact sidewall 626 of the chamber 620when the infusion device 600 is in a compressed state, friction fittingbetween the upper body 636 and sidewall 626 can be achieved therebyfurther securing of the upper body 636 to the lower body 644. However,in some embodiments the gap 672 is sized to avoid contact with butinstead only covers the sidewall 626.

Accordingly, use of the device as shown in FIGS. 6A-J can provide amethod of delivering medication into or through an implanted medicalport, which includes providing the infusion device 600 in a collapsedconfiguration, aligning the needle 628 with an implanted infusion port,and pressing the infusion device 600 such that needle 628 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the upper body 636, or base 630 maybe flattened, convex, concave, flanged, curved or suitably shaped toaccept a hand or finger to assist in securely gripping or pressing theinfusion device 600. Once the needle 628 pierces the skin and isinserted into the patient's infusion port, the base 630 is optionallyadhesively mounted to the patient through the use of adhesive mountspositioned along the underside of the base 630 or by applying tape overan outward extending flange of the base 630. Infusion of a medicalsample is accomplished by delivering the sample through the firstchannel 634, which is fluidly coupled to the needle 628, and into theimplanted infusion port.

After infusion is complete, the upper body is pulled or fluid isintroduced into the expandable chamber 620 to initiate chamber 620filling at a sufficient force to overcome friction fit attachmentbetween the upper body 636 and base 630 and optionally between the upperbody 636, sheath 668 and sidewall 626, thereby unfolding the bellows andupwardly extending the chamber sidewall 626. The skilled artisan willappreciate that the fluid may be any suitable fluid such as water,saline, phosphate buffered saline, wash solution, bleach solution orother liquids. Alternatively, compressed gas, such as compressed air,can be applied to the chamber 620. Preferably, fluid is continuallyintroduced at least until the needle 628 is withdrawn from the port, anduntil the bevel or tip of the needle 628 is at or above the lowermostplane of the lower body 644. In the expanded or deployed state theneedle 628 may remain captured within the pierceable barrier 646, whichacts to seal the bottom of the chamber 620. Alternatively, the needlecan be raised such that the bevel or tip is housed within the chamber620 and in particular sheathed by the sheath 668. Once the needle 628 isremoved from the port, the device 600 releases. Continued flow ofsolution into the chamber can then pass through the access port 670 andbackflush the needle 628, the first channel 634 and the tubing 638 asdesired. As with the embodiments above, a visual indicator may beemployed to monitor backflushing to ensure removal of potentiallyhazardous medication or solution and therefore may notify the user whenthe device 600 may be disposed of without special designation as ahazardous waste. In addition, further protection against needle stickcan be accomplished by providing a blocking structure configured toblock access through the piercable barrier 646 by the needle 628 uponexpansion of the chamber. Still further, the device 100 may include aremote valve along the tubing 638 to regulate flow into the needle 620and/or into the chamber 620.

Embodiments above can incorporate a blocking structure to prevent theneedle from traversing the entirety of the pierceable barrier afterexpansion of the chamber thereby further ensuring against needle stickinjury and exposure to infusion samples. The blocking structure can beprovided in a variety of configurations. In some embodiments, it is amaterial that is selectively presented between the tip of the needle andpierceable barrier, where the blocking structure is formed from amaterial that is not pierceable by the needle. Such structures can besuitably positioned for blocking during or at chamber expansion, such asbut not limited by spring action, hinged, through the use of memorymetals, or release from a suspended recess for positioning bygravitational forces. Such materials may be plastics of suitableformulation or thickness, metal, metal alloy or other materials that arenot pierceable using forces conventionally used during insertion of aneedle into a medical port. A related approach is shown in FIGS. 7A and7B where a blocking structure 780 in the form of a jam lock is upwardlysuspended by the needle 728 when in the collapsed configuration (FIG.7A) and is configured to fall and jam or wedge against the needle 728when in the expanded configuration (FIG. 7B), thereby preventing passageentirely across the pierceable barrier 746.

Embodiments herein can incorporate an external mechanical guide,preferably having an end of travel release, to further assist inupwardly guiding the upper body from the base during expansion of thechamber. This configuration further reduces the likelihood of the upperbody and thus needle from wobbling during expansion. An exemplaryexternal mechanical guide 882 is depicted in FIGS. 8A-B. Preferablythere are two external mechanical guides 882 positioned at opposingsides of the device 800. Each mechanical guide 882 is preferably formedas two rigid segments 882A, 882B hinged at about the center to permitfolding and unfolding thereby outwardly collapsing (FIG. 8A) andupwardly expanding (FIG. 8B) with the chamber 820. Preferably, themechanical guide 882 is joined to the base 844 at one end, such as bygluing or injection molding, and is releasably joined to the upper body836 at the opposing end, such as by a releasable hook 882C andcomplementary recess on the upper body 836. A hook 882C and recessconfiguration permits an end of travel release where the hook 882Crotates along the recess or slot until releasing when in the expandedstate if desired. The mechanical guide 882 is typically formed frompolymer plastic and narrowed at its center to form the hinge.

Each of the above embodiments herein can incorporate a valve positionedremote from the upper body for selectively connecting external sourcesto the chamber and/or needle. An exemplary configuration is shown inFIGS. 9A-B, where during the collapsed configuration (FIG. 9A), a remotevalve 958 is selected to permit flow through a first line 938A, such asby presenting the valve 958 with an upward extending body 959; andduring the expanded configuration (FIG. 9B), the valve 958 is selected,such as by pressing the body 959 downward, to permit flow through asecond line 938B (coupled to a wash solution) to access the chamber 920and backflush the needle and optionally first line 938A to removeresidual infusion sample.

In still another related embodiment a dual septum configuration isprovided, shown generally in FIGS. 10A-D, which can also be incorporatedinto any of the other embodiments herein. As with the other embodiments,the dual septum configuration preferably includes a chamber 1020, whichitself includes a collapsible sidewall 1026 connected to an upper body1036 and a lower body 1044. Again, the chamber 1020 is characterized inthat it has a collapsed state (FIG. 10A) and an expanded state (FIGS.10C-D). For completeness, FIG. 10B shows an intermediate step duringexpansion. In preferred embodiments, the lower body 1044 is sized and/orshaped for friction fitting into a mounting base akin to FIG. 1 .

As shown in FIG. 10A, the collapsed state is further characterized ashaving a needle 1028, preferably a non-coring or Huber needle affixed tothe upper body 1036, passing through the lower body 1044 and thus beingcapable of accessing a patient's implanted medical port. Fluidconnection between a remote source, including but not limited to asyringe or infusion pump, and the needle 1028 is accomplished in partthrough a first channel 1034 within the upper body 1036, which itself ispositioned at the upper end of the chamber 1020. In particular, thefirst channel 1034 of the upper body 1036 is fluidly connected to theneedle 1028 and can be fluidly coupled to tubing 1038 thereby permittinginfusion from a remote pumping source such as the syringe or infusionpump. Accordingly, a liquid medication can pass across through the firstchannel 1034, through the needle 1028 and into the patient.

In contrast, FIG. 10D depicts an expanded state (also referred to as adeployed state), characterized as having the bevel or tip of the needle1028 at or above the bottom most plane of the lower body 1044 to preventpassage of fluid out of the lower body 1044. Transitioning from acollapsed state to an expanded state, depicted generally in FIG. 10C,can occur by pulling the upper body 1036 or by filling the chamber 1020by pumping a fluid through a second channel (not shown but demonstratedthroughout FIGS. 1-9 ) that openly terminates to empty into the chamber1020. The chamber 1020 can be further guided upward through the additionof an external mechanical guide positioned outside of the collapsiblesidewall 1026 that upwardly guides the upper body 1036 from the lowerbody 1044 during expansion thereby further reducing wobble of the upperbody 1036 and thus needle 1028 during expansion of the chamber 1020. Theexternal mechanical guide can be joined at the lower end to the lowerbody 1044 and at the upper end to the upper body 1036.

The dual septum configuration was found to further improve sealing overwider testing parameters, yet still permits the needle 1028 to be easilyretracted. Preferably, the lower septum 1191 is attached to the lowerbody 1144, and the upper septum 1090 is pressed against or attached tothe lower septum 1091. Attachment can be by way of adhesive, fusing orany other suitable means for attachment known by those skilled in theart to which the invention belongs. As shown in FIG. 10C, while theneedle 1028 is being drawn upwards through the lower body 1044, thelower septum 1091 closes completely while the upper septum 1090 occludesthe needle 1028. In some embodiments, the needle 1028 continues to moveupwards and out of the upper septum 1090, as shown in FIG. 10D.

A septum's sealing pressure is characterized by (1) the force ofcompression on the needle 1028 when the needle 1028 is within a septum,(2) the tightness of the seal when the needle 1028 is not within theseptum, and (3) the level of pressure that the seal is able to withstandbefore breaking or opening. By using the double septum approach, thesealing pressure of the lower septum 1091 can be increased to ensure atight seal. Simultaneously, a lower relative sealing pressure in theupper septum 1090 ensures effective occlusion and ease of retraction.Increasing the sealing pressure of the septum may be by way ofincreasing compression of its material during formation. While a varietyof polymers may be used to form the septums, each is preferably formedfrom silicone.

The dual septum configuration was surprisingly found to have certainbenefits over a wider range of use than a single septum system.Experimentally it was found that in some instances when using a singleseptum as a pierceable barrier, the user did not completely withdraw theneedle from the septum/barrier, and in some of these instances fluidentering the chamber through the second channel ingressed into theseptum and hydraulically forced open the septum causing leakage.

Accordingly, the invention also provides a medical infusion device 1000,which includes a chamber 1020 characterized by an upper body 1036 joinedto a lower body 1044 by a reversibly collapsible sidewall 1026, wherethe upper body 1036 has a first channel 1034 fluidly coupled to a needle1028, and the lower body 1044 has a piercable barrier characterized as alower septum 1091 vertically aligned beneath an upper septum 1090 andwhere the lower septum 1091 forms a higher pressure seal than the upperseptum 1090. The chamber 1020 has a collapsed state and an expandedstate, where the collapsed state is characterized as the sidewall 1026being collapsed and the needle 1028 piercing entirely through the lowerseptum 1091 to deliver a fluid outside of the device 100, and theexpanded state characterized as the needle less than entirely piercingthrough the lower septum 1091.

In each dual septum configuration, the lower septum 1091 closescompletely even while the upper septum 1090 remains partially open dueto the presence of the retracted needle 1028 in the upper septum 1090.Using this technical approach, it was found that risk of hydraulic forceopening the lower septum 1091, and thus the pierceable barrier 1046, wassignificantly reduced over a wide range of users. In other words,separating the septums into two allows the lower septum 1091 to fullyclose so that it cannot be pried open by the needle 1028 and hydraulicpressure. Thus, the dual septum configuration reduces the risk ofcontamination by its sequential sealing effect over a wider range ofuse.

Relatedly, having a lower septum 1091 and an upper septum 1090sequentially stacked permits the lower septum 1091 to be configured witha much tighter seal to withstand higher pressures. A tighter sealreduces the risk of contamination and is thus a safer seal. A highpressure seal is able to withstand high pressures acting on it, withoutthe seal opening. However, a septum with a tight, high pressure sealalso compresses the needle 1028 and induces high frictional drag on theneedle 1028 while the needle 1028 is being drawn upwards or lowereddownwards. A high frictional drag on the needle 1028 could increasechance of user error. The dual septum configuration solves thischallenge by providing an upper septum 1090 and a lower septum 1091 andpressing them together allows the lower septum 1091 to be configuredwith a high pressure seal, while keeping the upper septum 1090 as alower pressure, preventive seal. Lowering seal pressure of the upperseptum 1090 reduces the drag on the needle 1028 while the needle isbeing drawn upwards or lowered downwards. Lowering the sealing pressurein the upper septum 1090 offsets the drag from the lower septum 1091.Thus, the dual septum configure provides a completely closed highpressure seal, together with relatively low needle drag.

The dual septum configuration is compatible with any of theconfigurations shown in FIGS. 1-9 . Furthermore, the upper body 1036 andlower body 1044 may be formed using conventional injection moldingtechniques with suitable polymers used in the formation of many medicaldevices such as polypropylenes or other polymers. Similarly, thesidewall 1026 of the chamber 1020 may be formed from rubber or foldablepolymer then adhered or fused to the upper body 1036 and lower body1044. The lower body 1044 may be provided with an aperture that iscovered or filled with self-sealing polymer or silicone to form thepierceable barrier 1046, which itself may be part of the lower septum1091.

Each septum, 1090, 1091, can be formed from materials and manufacturingmethods known to those in the medical device field. Each septum can beformed from a variety of materials that reversibly seal. Preferably theeach septum 1090, 1091 is formed from silicone but any self-sealingpolymer known in the medical device arts would be suitable.

Accordingly, use of the device as shown in FIGS. 10A-D can provide amethod of delivering medication into or through an implanted medicalport, which includes providing the infusion device 1000 in a collapsedconfiguration, aligning the needle 1028 with an implanted infusion port,and pressing the infusion device such that needle 1028 pierces thepatient's skin, then into the septum of the implanted port. To furtherassist with insertion or handling, the uppermost portion of the upperbody 1036, or a portion of the lower body 1044 may be flattened, convex,concave, flanged, curved or suitably shaped to accept a hand or fingerto assist in securely gripping or pressing the infusion device 1000.Once the needle 1028 pierces the skin and is inserted into the patient'sinfusion port, the lower body 1044 can be adhesively mounted to thepatient through the use of adhesive mounts positioned along theunderside of the lower body 1044 or by applying tape over outwardextending flanges of the lower body 1044. Infusion of a medical sampleis accomplished by delivering the sample through the first channel 1034,which is fluidly coupled to the needle 1028, and into the implantedinfusion port.

After infusion is complete, the user can either pull on the upper body1036 to retract the needle or introduce a fluid into the expandablechamber 1020 to upwardly extend the chamber sidewall 1026 to retract theneedle 1028 (as in described in FIGS. 1-9 ). In such alternativeapproaches skilled artisan will appreciate that the fluid may be anysuitable fluid such as water, saline, phosphate buffered saline, washsolution, bleach solution or other liquids. Alternatively, compressedgas, such as compressed air, can be applied to the chamber 1020.

In a preferred method, the needle 1028 is retracted completely from thelower septum 1091. In some embodiments the bevel or tip of the needle1028 is retracted to terminate at the upper septum 1090 for occlusion.In some embodiments the bevel or tip of the needle 1028 is retractedentirely to terminate above the upper septum 1090.

In still further embodiments the method includes introducing fluid intothe chamber to wash the needle (through a second channel consistent withFIGS. 1-9 ). In embodiments, which include the second channel, continuedflow of solution into the chamber would then backflush the needle 1028,first channel 1034, and optional tubing. As with the embodiment above, avisual indicator may be employed to monitor backflushing to ensureremoval of potentially hazardous medication or solution and thereforemay notify the user when the device 1000 may be disposed of withoutspecial designation as a hazardous material. Further protection againstneedle stick can be accomplished by providing a blocking structure, asshown in FIGS. 7A-B, configured to block access through the pierceablebarrier 1046 by the needle 1028 upon expansion.

A variation of the previous embodiment shown in FIGS. 10A-D, is shown inFIGS. 11A-C. The embodiment shown in FIGS. 11A-C is substantially thesame as that shown in FIGS. 10A-D, except the upper septum 1090 isreplaced by a channeled housing 1192, preferably a rigid cylindricalhousing 1192, and an o-ring 1193 is stacked sequentially above thecylindrical housing 1192 for sealing the channel.

Accordingly, a medical infusion device 1100, is provided, which includesa chamber 1120, an upper body 1136, a lower body 1144, and a collapsiblesidewall 1126. The upper body 1136 is located above the chamber 1120,and the lower body 1144 is located below the chamber 1120. The chamber1120 has a collapsible sidewall 1126. The chamber 1120 is characterizedin that it has a collapsed state (FIG. 11A), an expanded state (FIG.11C), and an intermediate state during expansion (FIG. 11B). The skilledartisan would appreciate that the lower body 1144 could be divided intoa detachable mounting base with lower body insert more akin to FIG. 1 ifdesired. As shown in FIG. 11A, the collapsed state is furthercharacterized as having a needle 1128, preferably a non-coring or Huberneedle affixed to the upper body 1136, passing through the lower body1144 and thus being capable of accessing a patient's implanted medicalport. Fluid connection between a remote source, including but notlimited to a syringe or infusion pump, and the needle 1128 isaccomplished in part through a first channel 1134 within an upper body1136, which itself is positioned at the upper end of the chamber 1120.In particular, the first channel 1134 of the upper body 1136 is fluidlyconnected to the needle 1128 and can be fluidly coupled to tubingthereby permitting infusion from a remote pumping source such as thesyringe or infusion pump. Accordingly, a liquid medication can passacross through the first channel 1134, through the needle 1128 and intothe patient.

In contrast, FIG. 11C depicts an expanded state (also referred to as adeployed state), characterized as having the bevel or tip of the needle1128 at or above the bottom most plane of the lower body 1144.Transition from a collapsed state to an expanded or deployed state canoccur by pulling the upper body 1136 or by filling the chamber 1120 witha fluid through a second channel (consistent with an approach in FIGS.1-9 ) within the upper body 1136. The chamber 1120 can be further guidedupward through the addition of an external mechanical guide positionedoutside of the collapsible sidewall 1126 that upwardly guides the upperbody 1136 from the lower body 1144 during expansion thereby furtherreducing wobble of the upper body 1136 and thus needle 1128 duringexpansion of the chamber 1120. The external mechanical guide can bejoined at the lower end to the lower body 1144 and at the upper end tothe upper body 1136.

In the embodiment shown in FIGS. 11A-C, the lower body 1144 has a septum1191 and a housing 1192 enclosing the needle 1128, and an o-ring 1193.The housing 1192 is preferably cylindrical. The lower end of the housing1192 is sealably attached to the septum 1191, while the upper end of thehousing 1192 is attached to the o-ring 1193 such that in combinationwith the needle 1128, the o-ring 1193 and the housing 1192 create a sealaround the needle 1128, isolating the septum 1191 and the pierceablebarrier 1146 from pressure within the lower body 1144 and/or within thechamber 1120. The attachment can be provided by any means known in theart by the skilled artisan, such as an appropriate adhesive.

FIGS. 12A-B show an alternative configuration of the collapsiblesidewall 1226. The collapsible sidewall 1226 in FIGS. 12A-B can be usedin the previous embodiments interchangeably with the sidewalls showntherein.

The collapsible sidewall 1226 is provided as a series of segments 1266a, 1266 b, between alternating folds 1268 a, 1268 b, that are foldablein a concentrically nested manner. Being foldable in a concentricallynested manner is characterized in that, while in the collapsed state(FIG. 12A), the segments 1266 are collapsed into a substantiallyvertical alignment with one another. The segments 1266 a and 1266 b arefurther optionally characterized in that while in an expanded state(FIG. 12B), the segments 1266 are in a substantially vertical alignmentwith one another. The segments 1266 a, 1266 b between folds 1268 a, 1268b, can be rigid, flexible, bendable, semi-flexible, and/or stretchable.The concentrically nested sidewall 1226, when in the collapsedconfiguration (FIG. 12A), provides for a lower overall height of thedevice 1200, which, among other advantages, allows for a lower, moreeconomical packaging volume when shipping the device 1200.

The invention described herein may be embodied in other specific formswithout departing from the spirit or essential characteristics thereof.The specific embodiments previously described are therefor to beconsidered as illustrative of, and not limiting, the scope of theinvention.

What is claimed is:
 1. A medical infusion device comprising: a chambercharacterized by an upper body joined to a lower body by a reversiblycollapsible sidewall, wherein the upper body comprises a first channelfluidly coupled to a needle and a second channel that is fluidly coupledto the chamber without passing through the needle, the lower bodycomprising a pierceable barrier that can be pierced by the needle,wherein the chamber has a collapsed state and an expanded state, thecollapsed state characterized as the sidewall being collapsed and theneedle piercing entirely through the pierceable barrier to deliver aliquid outside of the device, the expanded state characterized as theneedle less than entirely piercing through the pierceable barrier;characterized in that the chamber is configured to hydraulicallytransition from the collapsed state to the expanded state by introducingliquid into the interior of the chamber through the second channel tovolumetrically expand the chamber.
 2. The medical infusion deviceaccording to claim 1, wherein the needle is a non-coring needle and thepierceable barrier is a self-sealing septum.
 3. The medical infusiondevice according to claim 1, wherein the sidewall comprises a bellowsconfiguration formed as a plurality of segments joined by alternatingfolds configured to fold and unfold at predetermined fold lines.
 4. Amedical infusion device comprising: a chamber characterized by an upperbody joined to a lower body by a reversibly collapsible sidewall,wherein the upper body comprises a first channel fluidly coupled to aneedle and a second channel, the lower body comprising a pierceablebarrier that can be pierced by the needle, wherein the chamber has acollapsed state and an expanded state, the collapsed state characterizedby sidewall segments concentrically nested and the needle piercingentirely through the pierceable barrier to deliver a liquid outside ofthe device, the expanded state characterized as the needle less thanentirely piercing through the pierceable barrier; characterized in thatthe chamber is configured to hydraulically transition from the collapsedstate to the expanded state by introducing liquid into the interior ofthe chamber through the second channel to volumetrically expand thechamber.
 5. The medical infusion device according to claim 1, whereinthe second channel terminates at the interior of the chamber in both thecollapsed state and the expanded state.
 6. The medical infusion deviceaccording to claim 1, wherein the pierceable barrier is configured as alower septum positioned below an upper septum.
 7. The medical infusiondevice according to claim 6, wherein the lower septum forms ahigher-pressure seal compared to the upper septum.
 8. The medicalinfusion device according to claim 1, wherein the upper body furthercomprises a hydrophobic filter configured to permit outgassing of thechamber.
 9. The medical infusion device according to claim 1, furthercomprising a valve that selectively directs flow of liquid from outsideof the device into the first channel or the second channel.
 10. Themedical infusion device according to claim 9, wherein the valve formspart of the upper body.
 11. The medical infusion device according toclaim 1, further comprising a blocking structure positioned within thechamber and configured to block access to the pierceable barrier by theneedle when the chamber is in the expanded state.
 12. The medicalinfusion device according to claim 1, further comprising a rigid sheaththat sheathes the needle in the expanded state.
 13. A method ofdelivering medication into an implanted medical port, the methodcomprising: providing the medical infusion device in its collapsedstate, the device comprising: a chamber characterized by an upper bodyjoined to a lower body by a reversibly collapsible sidewall, wherein theupper body comprises a first channel fluidly coupled to a needle and asecond channel, the lower body comprising a pierceable barrier that canbe pierced by the needle, wherein the chamber has a collapsed state andan expanded state, the collapsed state characterized as the sidewallbeing collapsed and the needle piercing entirely through the pierceablebarrier to deliver a liquid outside of the device, the expanded statecharacterized as the needle less than entirely piercing through thepierceable barrier; characterized in that the chamber is configured tohydraulically transition from the collapsed state to the expanded stateby introducing liquid into the interior of the chamber through thesecond channel to volumetrically expand the chamber; piercing theimplanted medical port with the needle; infusing medication into themedical port through the needle via the first channel; and introducingliquid into the chamber via the second channel thereby volumetricallyexpanding the chamber to withdraw the needle from the medical port. 14.The method according to claim 13, wherein the pierceable barrier isconfigured as a lower septum positioned below an upper septum, themethod further comprising retracting the needle completely from thelower septum.
 15. The method according to claim 14, wherein the bevel ortip of the needle is retracted into the upper septum.
 16. The methodaccording to claim 14, wherein the bevel or tip of the needle isretracted entirely through the upper septum.
 17. The method according toclaim 13, further comprising continuing to introduce liquid into thechamber to wash the needle.
 18. The method according to claim 13,wherein the first channel is fluidly coupled to exterior tubing, themethod further comprising continuing to introduce liquid into thechamber to backflush the first channel and exterior tubing.